This study tests the effectiveness of different treatments for the three most commonly diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of two commonly prescribed treatments (surgery and nonsurgical therapy) works better for specific types of low back pain. Low back pain is one of the most widely experienced health problems in the United States and the world. It is the second most frequent condition, after the common cold, for which people see a doctor or lose days from work.

In this part of the study, we will treat patients with spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) with a type of surgery known as posterior decompressive laminectomy or with nonsurgical methods. This study does not cover the cost of treatment.

Removal of the hypertrophic inferior and superior articular facets will be performed when they are intruding upon the midline and causing both central and lateral recess stenosis.

Other: Non-surgical treatments

Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated

Active Comparator: Non-surgical treatments

Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated

Other: Non-surgical treatments

Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated

Detailed Description:

Low back pain is considered one of the most widely experienced health problems in the U.S. and the world. It is the second most frequent condition, after the common cold, for which patients see a physician or lose days from work. Estimated costs to those who are severely disabled from low back pain range from $30-70 billion annually. Rates of spinal surgery in the U.S. have increased sharply over time, and researchers have documented 15-fold geographic variation in rates of these surgeries. In many cases, where one lives and who one sees for the condition appear to determine the rates of surgery. Despite these trends, there is little evidence proving the effectiveness of these therapies over non-surgical management.

This study will use the National Spine Network to conduct a multicenter, randomized, controlled trial for the three most common diagnostic groups for which spine surgery is performed: lumbar intervertebral disc herniation (IDH), spinal stenosis (SpS), and spinal stenosis secondary to degenerative spondylolisthesis (DS). This arm of the trial will deal with patients from the second diagnostic group. The study will compare the most commonly used standard surgical treatments to the most commonly used standard nonsurgical treatments. We will conduct the study at 12 sites throughout the United States.

The primary endpoint of the study will be changes in health-related quality of life as measured by the SF-36 health status questionnaire. Secondary endpoints will include patient satisfaction with treatment, utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost-effectiveness, resource use, and cost.

We will follow patients at 6 weeks and 3, 6, 12, and 24 months to determine their health status, function, satisfaction, and health care use. We anticipate that we will enroll and randomly allocate a total of 370 study participants in this arm of the trial. We will track an additional observational cohort to assess health and resource outcomes. Enrollment in the Observational cohort has been completed as of February 2003.

We will integrate data from the trial and observational cohorts to formally estimate the cost-effectiveness of surgical versus nonsurgical interventions for IDH, SpS, and DS. The results of this trial will provide, for the first time, scientific evidence as to the relative effectiveness of surgical versus nonsurgical treatment for these three most commonly diagnosed lumbar spine conditions.

Surgical Screening: Pain in low back, buttocks, or lower extremity that becomes worse with lumbar extension. Must be confirmed by evidence of central or central-lateral compression of the cauda equina by a degenerative lesion of the facet joint, disc, or ligamentum flavum on MRI, computed tomography scans, or myelograms.

Tests: MRI to confirm diagnosis and level(s).

Exclusion Criteria:

Previous lumbar spine surgery.

Not a surgical candidate for any of these reasons: Overall health that makes spinal surgery too life-threatening to be an appropriate alternative, patient has improved dramatically with conservative care, or the patient is unable (for any reason) to undergo surgery within 6 months.

Possible pregnancy.

Active malignancy: Patients with a history of any invasive malignancy (except nonmelanoma skin cancer) are ineligible unless they have been treated with curative intent AND have not had any clinical signs or symptoms of the malignancy for at least 5 years.

Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine.

Unavailability for followup (planning to move, no telephone, etc.) or inability to complete data surveys.

Symptoms less than 12 weeks.

Patient currently enrolled in any experimental "spine related" study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000411

Locations

United States, California

Kaiser Permanente Spine Care Program

Oakland, California, United States, 94612

University of California, San Francisco (UCSF)

San Francisco, California, United States, 94143-0728

United States, Georgia

Emory University, The Emory Clinic

Decatur, Georgia, United States, 30033

United States, Illinois

Rush-Presbyterian, St. Luke's Medical Center

Chicago, Illinois, United States, 60612-3833

United States, Maine

Maine Spine & Rehabilitation

Scarborough, Maine, United States, 04074

United States, Michigan

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073-9952

United States, Missouri

Washington University

St. Louis, Missouri, United States, 63110

United States, Nebraska

Nebraska Foundation for Spinal Research

Omaha, Nebraska, United States, 68154-4438

United States, New Hampshire

Dartmouth-Hitchcock Medical Center - Spine Center

Lebanon, New Hampshire, United States, 03756

United States, New York

New York University, The Hospital for Joint Diseases

New York, New York, United States, 10003

Hospital for Special Surgery

New York, New York, United States, 10021

United States, Ohio

Case Western Reserve University

Cleveland, Ohio, United States, 44106

United States, Pennsylvania

Rothman Institute at Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107-4216

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)